Forced Degradation Products of Liraglutide: A Comparative Study of Similarity Between Originator and Analogue Version by Liquid Chromatography–Mass Spectrometry

ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry (2021). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-certain-highly-purified-synthetic-peptide-drug-products-refer-listed-drugs-rdna-origin. Accessed 24 Dec 2022

Arrahman A, Kazandjian TD, Still KBM et al (2022) A combined bioassay and nanofractionation approach to investigate the anticoagulant toxins of mamba and cobra venoms and their inhibition by varespladib. Toxins (Basel) 14:736. https://doi.org/10.3390/toxins14110736

Article  PubMed  Google Scholar 

Benet A, Halseth T, Kang J et al (2021) The effects of pH and excipients on exenatide stability in solution. Pharmaceutics 13:1263. https://doi.org/10.3390/PHARMACEUTICS13081263/S1

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bothe JR, Andrews A, Smith KJ et al (2019) Peptide oligomerization memory effects and their impact on the physical stability of the GLP-1 agonist liraglutide. Mol Pharm 16:2153–2161. https://doi.org/10.1021/acs.molpharmaceut.9b00106

Article  CAS  PubMed  Google Scholar 

Chan CP (2016) Forced degradation studies: current trends and future perspectives for protein-based therapeutics. Expert Rev Proteomics 13:651–658. https://doi.org/10.1080/14789450.2016.1200469

Article  CAS  PubMed  Google Scholar 

De Groot AS, Roberts BJ, Mattei A et al (2023) Immunogenicity risk assessment of synthetic peptide drugs and their impurities. Drug Discov Today 28:103714. https://doi.org/10.1016/j.drudis.2023.103714

Article  CAS  PubMed  Google Scholar 

Dong S, Gu Y, Wei G et al (2018) Determination of liraglutide in rat plasma by a selective liquid chromatography-tandem mass spectrometry method: application to a pharmacokinetics study. J Chromatogr B Analyt Technol Biomed Life Sci 1091:29–35. https://doi.org/10.1016/j.jchromb.2018.05.020

Article  CAS  PubMed  Google Scholar 

Duivelshof BL, Fekete S, Guillarme D, D’Atri V (2019) A generic workflow for the characterization of therapeutic monoclonal antibodies—application to daratumumab. Anal Bioanal Chem 411:4615–4627. https://doi.org/10.1007/s00216-018-1561-1

Article  CAS  PubMed  Google Scholar 

Duncan MW, Gibson DS (2012) Mass spectrometry for peptide and protein analysis. Encyclopedia of analytical chemistry. Wiley, Chichester

Google Scholar 

Elbrønd B, Jakobsen G, Larsen S et al (2002) Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects. Diabetes Care 25:1398–1404. https://doi.org/10.2337/diacare.25.8.1398

Article  PubMed  Google Scholar 

Fincke A, Winter J, Bunte T, Olbrich C (2014) Thermally induced degradation pathways of three different antibody-based drug development candidates. Eur J Pharm Sci 62:148–160. https://doi.org/10.1016/j.ejps.2014.05.014

Article  CAS  PubMed  Google Scholar 

Frederiksen TM, Sønderby P, Ryberg LA et al (2015) Oligomerization of a glucagon-like peptide 1 analog: bridging experiment and simulations. Biophys J 109:1202–1213. https://doi.org/10.1016/J.BPJ.2015.07.051

Article  CAS  PubMed  PubMed Central  Google Scholar 

Gallo M, Vanni D, Esposito S et al (2022) Oligomerization, albumin binding and catabolism of therapeutic peptides in the subcutaneous compartment: an investigation on lipidated GLP-1 analogs. J Pharm Biomed Anal 210:114566. https://doi.org/10.1016/J.JPBA.2021.114566

Article  CAS  PubMed  Google Scholar 

Goebel-Stengel M, Stengel A, Taché Y, Reeve JR (2011) The importance of using the optimal plasticware and glassware in studies involving peptides. Anal Biochem 414:38–46. https://doi.org/10.1016/J.AB.2011.02.009

Article  CAS  PubMed  PubMed Central  Google Scholar 

Grassi L, Cabrele C (2019) Susceptibility of protein therapeutics to spontaneous chemical modifications by oxidation, cyclization, and elimination reactions. Amino Acids 51:1409–1431. https://doi.org/10.1007/S00726-019-02787-2

Article  CAS  PubMed  Google Scholar 

Halley J, Chou YR, Cicchino C et al (2020) An industry perspective on forced degradation studies of biopharmaceuticals: survey outcome and recommendations. J Pharm Sci 109:6–21. https://doi.org/10.1016/J.XPHS.2019.09.018

Article  CAS  PubMed  Google Scholar 

Han X, Cheng F, Jie B et al (2021) Identification and characterization of new impurities in zopiclone tablets by LC-QTOF-MS. J Pharm Biomed Anal. https://doi.org/10.1016/j.jpba.2021.114056

Article  PubMed  Google Scholar 

Hawe A, Wiggenhorn M, van de Weert M et al (2012) Forced degradation of therapeutic proteins. J Pharm Sci 101:895–913. https://doi.org/10.1002/JPS.22812

Article  CAS  PubMed  Google Scholar 

Hinterholzer A, Stanojlovic V, Regl C et al (2021) Detecting aspartate isomerization and backbone cleavage after aspartate in intact proteins by NMR spectroscopy. J Biomol NMR 75:71–82. https://doi.org/10.1007/S10858-020-00356-4/TABLES/3

Article  CAS  PubMed  PubMed Central  Google Scholar 

Huang TY, Chi LM, Chien KY (2018) Size-exclusion chromatography using reverse-phase columns for protein separation. J Chromatogr A. https://doi.org/10.1016/j.chroma.2018.08.020

Article  PubMed  PubMed Central  Google Scholar 

Jia M, Mozziconacci O, Abend A et al (2022) Multi-dimensional plug-and-play liquid chromatography-native ion mobility mass spectrometry method for the analysis of biotherapeutics. Int J Mass Spectrom 471:116725. https://doi.org/10.1016/J.IJMS.2021.116725

Article  CAS  Google Scholar 

Knudsen LB, Lau J (2019) The discovery and development of liraglutide and semaglutide. Front Endocrinol (Lausanne). https://doi.org/10.3389/fendo.2019.00155

Article  PubMed  Google Scholar 

Kurtzhals P, Østergaard S, Nishimura E, Kjeldsen T (2023) Derivatization with fatty acids in peptide and protein drug discovery. Nat Rev Drug Discov 22:59–80. https://doi.org/10.1038/s41573-022-00529-w

Article  CAS  PubMed  Google Scholar 

Kyriakopoulos S, Kontoravdi C (2013) Analysis of the landscape of biologically-derived pharmaceuticals in Europe: dominant production systems, molecule types on the rise and approval trends. Eur J Pharm Sci 48:428–441. https://doi.org/10.1016/j.ejps.2012.11.016

Article  CAS  PubMed  Google Scholar 

Lau JL, Dunn MK (2018) Therapeutic peptides: historical perspectives, current development trends, and future directions. Bioorg Med Chem 26:2700–2707. https://doi.org/10.1016/J.BMC.2017.06.052

Article  CAS  PubMed  Google Scholar 

Leginus J (2014) CENTER FOR DRUG EVALUATION AND RESEARCH. Chemistry Review NDA 206321 SaxendaTM (Liraglutide [rDNA origin] Injection) for the division of metabolism and endocrinology products CHEMISTRY REVIEW #1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206321Orig1s000ChemR.pdf

Li J, Merkler DJ, Han Q (2023) Editorial: aromatic amino acid metabolism–volume II. Front Mol Biosci. https://doi.org/10.3389/fmolb.2022.1122151

Article  PubMed  PubMed Central  Google Scholar 

Lou W, Stimple SD, Desai AA et al (2021) Directed evolution of conformation-specific antibodies for sensitive detection of polypeptide aggregates in therapeutic drug formulations. Biotechnol Bioeng 118:797–808. https://doi.org/10.1002/BIT.27610

Article  CAS  PubMed  Google Scholar 

Luo Q, Joubert MK, Stevenson R et al (2011) Chemical modifications in therapeutic protein aggregates generated under different stress conditions. J Biol Chem 286:25134–25144. https://doi.org/10.1074/JBC.M110.160440

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mathieu Verbeken SVD (2012) Purity profiling of peptide drugs. J Bioanal Biomed. https://doi.org/10.4172/1948-593X.S6-003

Article  Google Scholar 

Meier JJ (2012) GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol 8:728–742. https://doi.org/10.1038/nrendo.2012.140

Article  CAS  PubMed  Google Scholar 

Molineau J, Hideux M, Hennig P et al (2022) Analysis of short-chain bioactive peptides by unified chromatography-electrospray ionization mass spectrometry. Part II. Comparison to reversed-phase ultra-high performance liquid chromatography. J Chromatogr A. https://doi.org/10.1016/j.chroma.2021.462771

Article  PubMed  Google Scholar 

Müller TD, Blüher M, Tschöp MH, DiMarchi RD (2022) Anti-obesity drug discovery: advances and challenges. Nat Rev Drug Discov 21:201–223. https://doi.org/10.1038/s41573-021-00337-8

Article  CAS  PubMed  Google Scholar 

Pan C, Liu F, Motto M (2011) Identification of pharmaceutical impurities in formulated dosage forms. J Pharm Sci 100:1228

Article  CAS  PubMed  Google Scholar 

Patel S, Vyas VK, Mehta PJ (2023) A review on forced degradation strategies to establish the stability of therapeutic peptide formulations. Int J Pept Res Ther 29:22. https://doi.org/10.1007/s10989-023-10492-8

Article  CAS  Google Scholar 

Pérez-Robles R, Salmerón-García A, Hermosilla J et al (2023) Comprehensive physicochemical characterization of a peptide-based medicine: teduglutide (Revestive®) structural description and stress testing. Eur J Pharm Biopharm 184:103–115. https://doi.org/10.1016/j.ejpb.2023.01.001

Article  CAS  PubMed 

留言 (0)

沒有登入
gif